Kornimate/medical-research-clean huggingface dataset:
sequential vaccination of poliomyelitis vaccine (vero cells), inactivated, sabin strains from different manufacturers

Conditions: Poliomyelitis

Summary: to evaluate the immunogenicity and safety of sequential vaccination with sinovac sipv among infants who have received two doses of biological products co., ltd. sipv.

in this study, two hundred infants ≤ 12 months of age vaccinated with two doses of sipv produced by beijing institute of biological products co., ltd., will be enrolled with a balanced male-to-female ratio. after enrollment with informed consent from the guardians of the participants, they will be divided into two groups, i.e., the study group and the control group, according to the 1:1 ratio. they will be vaccinated with one dose of the sipv produced by sinovac or the sipv produced by beijing institute, respectively. the 30-minute observation will be conducted after the vaccination. immediate reactions will be observed and solicited adverse events within 0-7 days, while unsolicited adverse events within 0-30 days will be collected to evaluate vaccine safety. about 2.5-3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination, and anti-poliovirus type 1, type 2, and type 3 neutralizing antibody tests will be performed to evaluate immunogenicity.

Eligibility criteria:
inclusion criteria: * (1) healthy infants of ≤ 12 months of age; * (2) can provide proof of legal identity; * (3) have completed two doses of sipv vaccination at beijing institute; * (4) able to provide proof of sipv vaccination; * (5) the participant's guardian can understand and agree to sign the informed consent form. exclusion criteria: * (1) known severe allergy to vaccines or vaccine components, such as urticaria, dyspnea, angioneurotic edema; * (2) received immunoglobulins or other blood products, or plan to receive such treatment during the study; * (3) received ≥14 days of immunosuppressive or other immunomodulatory therapy or cytotoxic therapy, or plan to receive such therapy during the study; * (4) received another investigational vaccine within 28 days before receiving the study vaccine; * (5) received a live attenuated vaccine within 14 days before receiving the trial vaccine; * (6) received a subunit or inactivated vaccine within 7 days before receiving the trial vaccine; * (7) acute exacerbation of various acute illnesses or chronic diseases within the last 7 days; * (8) those who had a fever with an axillary temperature \>37.0°c before receiving the study vaccine; * (9) participants who, in the judgment of the investigator, have any other factors that make them unsuitable for participation in the study.
effect of acetazolamide on right ventricular function during exercise in patients with respiratory disease at altitude

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function during exercise at acute altitude exposure in patients with copd.

this is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function during exercise in lowlanders with chronic obstructive pulmonary disease travelling to altitude. participants living in the bishkek area, kyrgyzstan (760m), will be transferred by car within 4h to the tuja ashu high altitude clinic (3200 m), and stay there for 2 days. acetazolamide 375mg/day (or placebo) will be administered 24 hours before departure at 760 m and during the stay at altitude. outcomes will be assessed during the stay at 3200 m. right ventricular function will be assessed during graded cycling on an ergometer by transthoracic echocardiography.

Eligibility criteria:
inclusion criteria: * male and female patients, age 18-75 yrs. * copd diagnosed according to gold, fev1 40-80% predicted, spo2 ≥92% at 750 m. * born, raised and currently living at low altitude (\<800m). * written informed consent. exclusion criteria: * copd exacerbation, very severe copd with hypoxemia at low altitude (fev1/fvc \<0.7, fev1 \<40% predicted, oxygen saturation on room air \<92% at 750 m). * comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; osa; pneumothorax in the last 2 months. * internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\>20 cigarettes per day) * known renal failure or allergy to acetazolamide and other sulfonamides

Keywords: exercise echocardiography right ventricular function obstructive airway disease emphysema acetazolamide altitude
tetrahydrocannabinol (thc) and sleep

Conditions: Sleep; THC; Marijuana; Cannabis

Summary: the investigators will test the effects of 10-60mg dronabinol (oral thc) on sleep in non-frequent and frequent cannabis users.

the investigators plan to test the effects of 10-60 mg dronabinol (oral thc) on subjective (surveys) and objective (polysomnographically scored (psg)) sleep in non-frequent and frequent cannabis users following an acclimation and baseline night of sleep. the mornings after baseline sleep and dronabinol administration, cognitive performance will also be measured and participants may also perform morning typical behaviors such as change in posture (getting out of bed/tilt test) and mild intensity physical activity. this pilot study is in healthy young adults without a history of chronic disease.

Eligibility criteria:
inclusion criteria: * frequent cannabis use (\>3x/week for the prior 3 months) or * no cannabis use (less than 10x ever) exclusion criteria: * sleep apnea * pregnancy * diabetes * cardiovascular disease * chronic pain * history of seizures * severe hepatic impairment * conditions associated with clinically relevant cognitive impairment * symptoms of acute or active illness (e.g., fever and leukocytosis) * evidence of psychopathology on the beck depression index ii (bdi-ii or in a structured clinical interview with a physician * history of severe psychiatric illnesses (including such as alcoholism, drug dependency including a cannabis use disorder score ≥12 on the cannabis use disorders identification test (cudit) (28) or \>1 withdrawal symptom on the marijuana withdrawal checklist (mwc (29)) , major depression, manic depressive illness, schizophrenic disorders, panic disorder, generalized anxiety disorder, post-traumatic stress disorder, agoraphobia, claustrophobia, paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder, borderline personality disorder, and antisocial personality disorder.) * history of having been treated with antidepressants, neuroleptic medications, or tranquilizers. * volunteers must be drug-free (including caffeine, nicotine, alcohol and herbal medications) for the duration of the screening and study period (with the exception of thc), with no dependence on drugs (e.g. cocaine, opioids, amphetamine, methamphetamine, pcp, benzodiazepines, barbiturates, methadone, mdma); or alcohol dependency. * current nicotine use ( or history of more than 5 'pack years' of smoking) * current use of prescription or over the counter medications * history of shift work in the last 6 months * travel across \>2 time zones during the month prior to the study * habitual bedtime after 1am or waketime before 5am
measuring blood flow in the brain

Conditions: Traumatic Brain Injury; Healthy

Summary: this study will test a method of measuring brain blood flow called near infrared spectroscopy (nirs). it will determine whether nirs gives the same results as the more commonly used technique, functional magnetic resonance imaging (fmri). healthy normal volunteers between 18 and 60 years of age may be eligible for this study. participants come to the nih up to six times for experiments using nirs and fmri. they do the following tasks while they are undergoing nirs or fmri: * looking at a computer monitor while a checkerboard pattern changes * wiggling the toes and moving the fingers * reading words on a computer screen and pushing one button if they are plants and another if they are animals. for nirs, a frame is placed on the head and held it in place with a metal band. the frame holds sensors that contact the scalp. for fmri, the subject lies on a table that can slide in and out of an mri scanner, a metal cylinder surrounded by a strong magnetic field. fmri uses a strong magnetic field and radio waves to obtain images of the brain while the subject performs tasks. during the procedure, the subject wears earplugs to muffle the sound of loud knocking noises that occur during scanning.

objective: a) to explore the usefulness of near infrared spectroscopy (nirs) as a means of mapping brain activity, to see whether the results are similar to those of fmri and b) to see whether spontaneous brain blood flow changes coincide with changes in behavior. study population: 50 healthy volunteers. design: the study will look for correlations between nirs and fmri signal changes in the same subjects. it will also detect relationships between spontaneous blood flow shifts and shifts and changes in cognitive performance. finally, nirs will be combined with a frontal lobe activation task to see if blood flow changes can be detected over the hairless skin of the forehead in a simple, standardized manner that might yield a diagnostic test for frontal injury. outcome measures: graded changes in blood flow and oxygen, measured with nirs and fmri and variations in response time on a word task.

Eligibility criteria:
* inclusion criteria: age 18 to 60, inclusive. exclusion criteria: * pregnancy. * history of hypertension. * history of any disease of the central nervous system. * current use of sedating medication, including antihistamines. * subjects with any of the following will be excluded from mri testing: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body, such as metal shavings; permanent eyeliner; insulin pump; or irremovable body piercing due to the possible dangerous effects of the mri magnet upon metal objects in the body.

Keywords: cerebral blood flow cerebral cortex cognition optical imaging healthy volunteer hv
bupropion as a smoking cessation aid in alcoholics

Conditions: Alcoholism; Smoking

Summary: the purpose of this study is to test the use of time-released bupropion (wellbutrin) in patients receiving treatment for alcohol abuse/dependence as an aid to stop smoking. patients will receive either a time-released bupropion or placebo. both groups will receive nicotine replacement therapy during the 9 week study. a final followup assessment will be conducted 6 months from the start of treatment.


Eligibility criteria:
inclusion criteria: * currently a patient in the omaha va medical center, substance abuse treatment center (satc) or at catholic charities campus for hope. * have a diagnosis of alcohol abuse or alcohol dependence. * smoke 20 or more cigarettes/day (may also smoke pipes/cigars). * be interested in quitting smoking. * provide name, addresses, and phone numbers of at least two individuals who can provide information on their alcohol, nicotine, and other drug use during the follow-up period. * if female, patient must a) be of non-childbearing potential, b) have a negative pregnancy test, c) sign a document stating they do not plan on becoming pregnant during the study. * agree to sign informed consent. * able to read and understand study-related forms and procedures. exclusion criteria: * advanced cardiac, pulmonary, renal, or liver disease. * history of seizures. * history of brain tumor or significant head trauma. * history of bulimia or anorexia nervosa. * current major depressive disorder or past history of panic disorders, schizophrenia, or bipolar affective disorder. * using psychoactive drugs. * receiving treatment with medications that lower seizure thresholds. * use of an investigational drug in any study in the past four weeks. * currently using any asthma medication. * used time-released bupropion in the past 12 months. * currently using any other treatments to stop smoking.
a phase i/ii study of the pan-immunotherapy in patients with local advanced/metastatic btc

Conditions: Biliary Tract Cancer (BTC)

Summary: biliary tract cancer (btc) is a rare heterogeneous collection of malignancies arising within the biliary tract, characterized by innate chemoresistance and abysmal prognosis. pd-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance t-cell-mediated anticancer immune responses. manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. this open-label, phase i/ii study is designed to assess the safety and efficacy of manganese primed combined therapy of anti-pd-1 antibody and gemcitabine/cisplatin chemotherapy.


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years old. 2. life expectancy of at least 3 months. 3. subjects must have histopathological/cytological diagnosis of unresectable or recurrent /metastatic biliary tract carcinoma (intra-hepatic, extrahepatic or gall bladder). 4. eastern cooperative oncology group performance status 0-2. 5. subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria. 6. subjects may have received prior radiotherapy, chemotherapy, or other local ablative therapies, which completed ≥ 4 weeks prior to registration and patient has recovered to \<= grade 1 toxicity. 7. subjects with anti-pd-1 antibody treatment history are eligible which must be resistance. 8. adequate organ function. 9. participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug. exclusion criteria: 1. subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2. serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3. prior organ allograft. 4. women who are pregnant or breastfeeding. 5. women with a positive pregnancy test on enrollment or prior to investigational product administration. 6. subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Keywords: local advanced metastatic anti-pd-1 antibody manganese gemcitabine cisplatin
longitudinal assessment of adjacent tooth health following implant placement

Conditions: Dental Implants; Postoperative Period; Endodontics; Health

Summary: this study is a cohort investigation involving patients scheduled to receive dental implants in edentulous sites adjacent to natural teeth. individuals aged between 18 and 65 years, without any systemic diseases and possessing natural teeth adjacent to the planned implant sites, were included. clinical and radiographic evaluations were conducted preoperatively, and at 1 week, 1 month, and 3 months following implant placement. the null hypotheses (h0) of this study are as follows: first, there is no significant difference in the clinical parameters of adjacent teeth before and after implant surgery. second, there is no significant change in the radiological parameters in adjacent teeth between the preoperative and postoperative periods.

modern implantology began in 1965 with the placement of four intraosseous titanium implants in a patient with a mandibular defect, marking the introduction of the concept of osseointegration. since then, dental implants have emerged as a reliable and effective treatment modality for the rehabilitation of edentulous spaces. this longitudinal cohort study aims to evaluate whether dental implants placed in edentulous sites adjacent to natural teeth lead to alterations in the endodontic condition of these neighboring teeth. specifically, the study investigates the nature and extent of any pulpal or periapical changes in adjacent teeth following implant placement. it is hypothesized that any damage to the adjacent teeth may be attributed to intraoperative complications, iatrogenic factors, or physiological consequences associated with the healing of hard and soft tissues post-surgery. the short-term observation intervals (1 week, 1 month, and 3 months postoperatively) are expected to offer insights into the potential causes of endodontic symptoms that may arise in neighboring teeth. through this design, the study seeks to better understand the etiological relationship between implant placement and the pulpal/periapical health of adjacent teeth.

Eligibility criteria:
inclusion criteria: age between 18 and 65 years asa i or ii classification at least one vital adjacent tooth at implant site adjacent tooth free of pulpal/periapical pathology not prosthetically restored; unrestored or restored with composite material sites allowing a tooth-implant distance of ≥1.5 mm patients scheduled to receive multiple implants at different time points based on surgical planning exclusion criteria: age \ 65 asa physical status classification ≥ iii absence of adjacent teeth at implant site undergoing or planned advanced implant procedures (e.g., bone grafting, sinus lifting, nerve lateralization/transposition) adjacent teeth devital, with periapical pathology, root canal treated, or prosthetically rehabilitated

Keywords: dental implants postoperative monitoring adjacent teeth pulpal health
role of adipokines in glucose regulation during pregnancy and in fetal development

Conditions: Gestational Diabetes; Insulin Resistance; Obesity Prevention

Summary: this study includes 2 phases. during phase 1, pregnant women are followed over the course of pregnancy. the phase 2 is a follow-up of the mother-child dyad at 3, 5 and 10-12 year after delivery. the purpose of this phase 1 is to : * assess the contribution and interactions of adipokines in the development of insulin resistance during pregnancy and gestational diabetes; * assess levels of maternal adipokines as determinants of development and fetal growth; * determine the genetic variations that influence levels of adipokines and glucose regulation during pregnancy and in newborns. the purpose of this phase 2 is to: * identify dna methylation variations at birth that are predictive of childhood overweight/obesity. * identify maternal characteristics associated with dna methylation variations predictive of childhood overweight/obesity. * establish whether the loci predictive of childhood overweight/obesity at birth are still differentially methylated at 5 years of age (samples collected at 5 years of age). * identify dna methylation variations at birth that are predictive of childhood neurodevelopment problems at 3, 5 and 10 years of age.


Eligibility criteria:
inclusion criteria: * age ≥ 18 yrs * gestational age between 6 and 13 weeks from last menstrual period * no recognized diabetes or drugs interfering with glucose metabolism * alcohol \< 2 drinks/day * not involved in regular high intensity physical activity * otherwise good health status exclusion criteria: * twin pregnancy

Keywords: gestational diabetes adiponectin leptin single nucleotides polymorphisms insulin resistance obesity
efficacy and safety of medi7352 in participants with painful diabetic neuropathy

Conditions: Painful Diabetic Neuropathy

Summary: this is a study investigating the effect of medi7352 on chronic pain in participants with painful diabetic neuropathy. the study incudes a screening period of up to 45 days and a 12-week treatment period during which medi7352 or placebo will be administered intravenously (iv) on 6 occasions, with each dose separated by 14 days. there will be a 6-week follow-up period. participants will randomly be assigned to double-blind treatment with one of 4 dose levels of medi7352 or placebo.


Eligibility criteria:
key inclusion criteria: * male, or postmenopausal or surgically sterile female, 18 to 80 years of age * body mass index of ≤ 42 kg/m\^2. * chronic painful diabetic neuropathy (pdn) persistent for 6 months or longer, not adequately controlled by standard of care treatments. * mean pain intensity score of ≥ 4, as measured on an 11-point (0-10) numerical rating scale (nrs). * willing and able to discontinue all non-steroidal anti-inflammatory drug (nsaid) or cyclooxygenase-2 (cox-2) analgesic therapy. * currently be taking medication for the treatment of pdn. participants should be taking at least one of the first-line medications (consistent with regional or local standard of care guidelines for pdn). key exclusion criteria: * presence of other clinically significant neuropathy (eg, hereditary neuropathy, inflammatory neuropathy) or other clinically significant disorder (eg, nerve compression injury) involving abnormal peripheral sensation, with an aetiology that is considered to be distinct from that of pdn, and that is likely to interfere with assessment of peripheral nerve function, as judged by the investigator. * history of osteonecrosis, rapidly progressing osteoarthritis (oa), subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy. * diagnosis of clinically significant oa currently affecting a major joint in the upper extremity (shoulder, elbow, or wrist) or lower extremity (hip, knee, or ankle) or axial spine; or other degenerative disease affecting any joint in participants for whom, in the opinion of the investigator, there is an identified risk of osteonecrosis, rapidly progressing oa, subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy. * chronic pain condition, other than pdn, that is likely to interfere with the evaluation of the participant's pdn pain, as judged by the investigator. * haemoglobin a1c greater than 10.0% (\> 10.0%).
safety study to evaluate immune response of vaccines in participants with relapsing forms of multiple sclerosis who receive ozanimod compared to non-pegylated interferon (ifn)-β or no disease modifying therapy

Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Summary: this study is designed to provide data on the immune response and safety of administering vaccines to relapsing multiple sclerosis (rms) participants taking ozanimod compared to controls taking interferon-beta's or receiving no disease modifying therapies (dmts). the data of this study will support the labels for ozanimod in multiple sclerosis (ms) because the effect of ozanimod on the vaccination response of ms participants is of interest to participants and prescribers.


Eligibility criteria:
inclusion criteria: * participant has a diagnosis of multiple sclerosis (ms) according to the 2017 revision of the mcdonald diagnostic criteria and has relapsing forms of multiple sclerosis (rms): relapsing-remitting ms (rrms) or secondary progressive ms with active disease based on recent clinical relapse or mri lesion activity. exclusion criteria: * participant has history of cancer, including solid tumors and hematological except for basal cell cancer of the skin and carcinoma in situ of the cervix, which are exclusionary if they have not been excised and resolved. * participant has a history of or currently active primary or secondary immunodeficiency. * participant has severely compromised cardiac or pulmonary function for which a systemic hypersensitivity reaction to any of the vaccines would pose a significant risk. * participant has received the seasonal influenza vaccine for the 2021/2022 influenza season prior to day 1, or history of influenza vaccine for the 2020/2021 influenza season within 6 months prior to day 1. * participant has previous treatment with one of the following medications or interventions within the corresponding timeframe described as follows: * any systemic immunosuppressive treatments with potential overlapping effects with the baseline of this study. corticosteroids that are by non-systemic routes (e.g., topical, inhaled, intra-articular) are allowed. * history of treatment with iv immunoglobulin (ivig) or plasmapheresis within 4 weeks prior to day 1.

Keywords: multiple sclerosis ozanimod relapsing-remitting multiple sclerosis